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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005648-10 | EudraCT Number |
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To evaluate the safety and tolerability of single- and multiple doses of Lu AE58054 in healthy young Japanese men in comparison with Caucasian men.
The study will be conducted in two parts.
Part A consists of two cohorts (named cohort A1 and A2), which are randomised, double-blind, parallel-group, placebo-controlled, single- and multiple dose regimens investigating the safety, tolerability, and pharmacokinetics of Lu AE58054 in healthy young men.
Part B consists of one cohort, B1, which is a randomised, open-label, two-way cross-over, single dose investigation of the effect of food on the pharmacokinetics of Lu AE58054 in healthy young Japanese men.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A1: Lu AE58054 or placebo | Experimental |
| |
| Cohort A2: Lu AE58054 or placebo | Experimental |
| |
| Cohort B1: Lu AE58054 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cohort A1: Lu AE58054 or placebo | Drug | One single oral dose 60 mg (one 60 mg tablet) followed by 60 mg once daily for 7 days, or matching placebo. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number and frequency of adverse events | Standard clinical safety assessments | Up to Day 13 |
| Number of subjects with adverse events | Adverse event monitoring | Up to Day 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the Lu AE58054 plasma concentration-time curve in a dosing interval (AUC0-tau) | Day 9 | |
| Area under the Lu AE58054 plasma concentration-time curve from zero to infinity (AUC0-inf) | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GB001 | London | NW10 7EW | United Kingdom |
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| Cohort A2: Lu AE58054 or placebo | Drug | One single oral dose 120 mg (two 60 mg tablets) followed by 120 mg once daily for 7 days, or matching placebo. |
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| Cohort B1: Lu AE58054 | Drug | Two single oral doses 60 mg with >=7 days washout. |
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| Maximum observed concentration (Cmax) and time of observation (tmax) | Day 1 and Day 9 |
| Oral clearance (CL/F), apparent volume of distribution (Vz/F), and elimination halflife (t½) | Day 1 and Day 9 |
| Accumulation index following multiple dosing of Lu AE58054 (AI) | Day 9 |
| Risk of Suicidality | Columbia Suicide Severity Rating Scale (C-SSRS) categorisation based on Columbian Classification Algorithm for Suicide Assessment (C-CASA) definitions for Part A | Up to Day 13 |